October 13, 2015

NIH and AHRQ Announce Changes for Policies, Instructions, and Forms in 2016

The National Institutes of Health and the Agency for Healthcare Research and Quality have published notices informing the biomedical and health services research communities of planned changes to policies, forms, and instructions for grant applications submitted in 2016.

The planned changes focus on the following areas: rigor and transparency in research, vertebrate animals, inclusion reporting, data safety monitoring, research training, appendices, font requirements, and biosketch clarifications.
    Announced changes will occur in two phases.

    Phase 1: Effective for NIH/AHRQ applications submitted for due dates on or after January 25, 2016.
    • Use of a new “Authentication of Key Biological and/or Chemical Resources” attachment (uploaded in Other Attachments section of R&R Other Project Information form)
    • Vertebrate Animals (applies to NIH but not AHRQ)
      • Updated guidance on criteria to be addressed (description of procedures; justifications; minimization of pain and distress; and euthanasia)
      • A description of veterinary care is no longer required
      • Justification for the number of animals has been eliminated
      • A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines for the Euthanasia of Animals
    • Definition of “child” (applies to NIH but not AHRQ) The age of a “child” for the purposes of NIH’s inclusion policy will apply to individuals who are 18 years old instead of under 21 years old.
    • Updated requirements and instructions for several attachments on the PHS 398 Research Training Program Plan form:
      • “Recruitment and Retention Plan to Enhance Diversity” - applicants will be asked to focus on recruitment
      • “Human Subjects” - applicants must describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information
      • “Vertebrate Animals” - applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information
      • “Progress Report” - requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process
    Phase 2: Completes the implementation with the introduction of new (FORMS-D) forms and instructions and will impact due dates on or after May 25, 2016.

    More information on this phase will be provided in 2016.

    See NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (NOT-OD-16-004) for additional details.


    In a related notice, NIH & AHRQ Announce Upcoming Changes to Post-Award Forms and Instructions (NOT-OD-16-005), NIH and AHRQ plan to change policies, forms, and instructions for interim and final progress reports, and other post-award documents associated the monitoring, oversight, and closeout of an award. This also applies to revised Ruth L. Kirschstein National Research Service Award (NRSA) forms.
    • Changes to Research Performance Progress Reports (RPPR)
      • As of 12/1/2015: New training data tables. See NOT-OD-15-112 and NOT-OD-16-007.
      • As of 1/22/2016: Updates Coming to the Screens in the Inclusion Management System (IMS). More information will be posted in a separate Guide Notice just prior to when the changes will be implemented.
      • As of 1/25/2016: Addition of clarifying rigor language. See NOT-OD-16-011 and NOT-OD-15-012.
    • Changes to the following forms also are anticipated:
      • PHS 2271— Statement of Appointment—as of 1/22/2016
      • PHS 416-7— NRSA Termination Notice—as of 1/22/2016
      • PHS 2590— Noncompeting Continuation Progress Report—as of 3/25/2016
      • Final Progress Report Instructions—as of 3/25/2016